The Health Information Technology for Economic and Clinical Health Act (“HITECH Act”) is part of the American Recovery and Reinvestment Act of 2009 (ARRA). The ARRA HITECH Act facilitates the expansion of the electronic exchange of health information on a national basis to make medical care more organized and transparent. It also contains incentives designed to accelerate the adoption of electronic health record (EHR) systems among providers.
The Nationwide Health Information Network (NHIN or NwHIN) is an interoperable health information infrastructure, developed for the purpose of securely connecting consumers, providers and others who have, or use, health-related data and services, while protecting the confidentiality of health information. NHIN provides a set of standards, services and policies that enable secure and meaningful health information exchange over the Internet.
The health information exchange (HIE or “the Exchange”) is the transmission of healthcare-related data among facilities, health information organizations (HIO) and government agencies according to national standards. The Exchange seeks to connect diverse entities needing to exchange health information, such as state and regional entities, integrated delivery networks (IDNs), personally controlled health records (PCHRs), federal and state government agencies, and their component networks. The Exchange permits the transmission of healthcare-related data among facilities, health information organizations (HIOs) and government agencies according to national standards.
Accordingly, interoperability has become a centerpiece for healthcare systems, providing a means to prevent fraud, waste, and abuse, improve quality of care, and improve the usability of medical information. Facilitating the secure exchange of health information is a system's interoperability architecture consisting of an Electronic Health Record (EHR), Electronic Medical Record (EMR), or other medical device, along with a gateway technology for sending and receiving well formatted web service calls. However, a system's interoperability architecture is delicate, and demonstrating interoperability is a difficult undertaking.
To meet requirements, the Exchange must enable reliable and secure transfer of data among diverse systems and also facilitate access and retrieval data. The Nationwide Health Information Network Validation Plan describes the approach, processes, and requirements for validating that an Applicant has met the requirements for participation in the Exchange. The intent of the Validation Plan is to describe the general principles and processes guiding validation for an Applicant to participate in the Exchange. To meet requirements for trust and interoperability in the Exchange, the validation process verifies Applicants can securely exchange information with other Exchange participants, while maintaining the privacy of the information exchanged. The validation approach seeks to confirm that an Applicant's technical implementation of NHIN specifications complies with the network performance and service specifications.
Participation in the Exchange is predicated on an Applicant meeting defined requirements for participation, including organizational, technical, and operational criteria. The Exchange validation process manually tests adherence to the specifications and technical criteria for participating in the Exchange. In order to successfully exchange information over the Exchange, an entity or Applicant must undergo an onboarding process. The onboarding process takes the Applicant's HIT gateway application through several phases, namely conformance testing (testing to ensure that the organization adheres to the NHIN specifications) and interoperability testing (testing to ensure that the organization can communicate with other NHIN participants using various services).
Generally, the onboarding process may be initiated when an Applicant requests and then submits an application to the Onboarding Team. The Team then reviews the application, and forwards it along to a Coordinating Committee for further review and eligibility determination. If eligible, the Onboarding Team sends test certificate and validation framework information to the Applicant. The Applicant configures its test environment and conducts conformance testing and interoperability testing. The Team collects testing logs from the Applicant and conducts its own analysis for conformance and interoperability testing. The Team then prepares a validation summary report, which is submitted to the Coordinating Committee. If required, the Applicant submits a remediation plan to the Onboarding Team for further review. The Coordinating Committee then provides a summary report and remediation plan (if applicable), and determines whether to grant conditional approval for the Applicant to attain participant status on the Exchange. The Applicant is then notified of participant status, and provided an activation packet. After receiving the activation packet from the Applicant, the Onboarding Team configures the Exchange registry with the Applicant's information. The Applicant is then an active participant and able to exchange data over the Exchange.
The onboarding process is very time consuming and relatively complicated. Within the Network, two concerns must be realized: that each participating system conforms to the applicable NHIN specifications, and that each participating system can interact with the others. Conformance does not necessarily guarantee interoperability. Similarly, interoperability does not necessarily guarantee conformance.
Manual testing tool systems have been utilized to test that an Applicant conforms to NHIN specifications, and to ensure that the Applicant system can interoperate with other NHIN participants for common business functions.
Conformance testing focuses on validating a single system to a specific set of standards and specifications. This testing primarily confirms that a system correctly encodes the syntax and structure of a given data standard in the physical files or transactions that a system produces and receives. Conformance testing is performed based on a set of resources, including test cases and data, testing guidance documents, supporting processes, and manual or automated test tools and capabilities.
Interoperability Testing seeks to validate that multiple systems implementing a particular standard or set of standards can all communicate with one another. Interoperability testing is performed based upon a set of resources, including interoperability test cases and scenarios, related criteria, test scripts, supporting processes, and automated testing tools. Although in theory passing interoperability tests implies interoperability between participating systems, such interoperability is not guaranteed. As such, it may be beneficial for an Applicant and/or participant system to conduct additional testing.
Thus, healthcare organizations must properly interoperate with one another for compliance. Although many organizations and vendors assume or assert that their electronic information (e.g., electronic health and medical records) are indeed interoperable with one another, many organizations and vendors are encountering difficulties in exchanging health information using standards outlined by various agencies, and are unable to properly exchange information. The architecture of many systems' interoperability components are fragile and prone to inoperability. Moreover, the numerous vendors and organizations utilize different means of interpreting standards and thus may not always implement a working system.